Femasys Inc. announced FDA Investigational Device Exemption (IDE) approval to continue enrollment in the final phase (Part B) of the FINALE pivotal trial for FemBloc, marking a critical step toward potential U.S. Pre-Market Approval for the first non-surgical permanent birth control solution. The milestone follows successful completion of Part A of the multi-stage trial design and represents significant progress in bringing women a long-awaited alternative to surgical sterilization.
The biomedical company simultaneously secured $12 million in senior secured convertible notes with accompanying warrants that could generate total proceeds of up to $58 million if all warrants are exercised for cash. The financing was led by existing investor Jorey Chernett and will be used to refinance existing debt and advance commercialization of Femasys' fertility and permanent birth control portfolio.
Revolutionary Non-Surgical Approach
FemBloc represents a first-of-its-kind solution addressing a significant unmet need in women's reproductive health. The device uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue for permanent occlusion. Unlike surgical sterilization, FemBloc requires no anesthesia, no incisions, and no recovery time, avoiding the risks of infection and other surgical complications while providing women a safer, more convenient, and affordable option.
"This FDA IDE approval represents a critical milestone in advancing FemBloc toward U.S. approval, bringing women a long overdue, non-surgical option for permanent birth control, as women in Europe and other select countries are now beginning to benefit from this important innovation," said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc.
International Market Success
FemBloc has already achieved regulatory success internationally, receiving full regulatory approval in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction. The device is being commercialized through strategic partnerships in select European countries.
Strong Investor Confidence
The financing reflects continued investor confidence in Femasys' mission to transform women's health. "The recent FDA IDE approval to advance FemBloc's final pivotal trial phase reinforces the company's tremendous progress toward bringing this long-overdue option to women in the U.S.," said Jorey Chernett, CEO and Founder of Clearpath and Managing Member of Pointillist Family Office. "Having witnessed firsthand the risks women have historically faced, I believe FemBloc and FemaSeed represent transformative innovations that redefine the standard of care."
Financial Structure
The Notes bear interest at 8.5% per annum with a 10-year maturity and are convertible into up to 16,378,563 shares of Femasys common stock at $0.73 per share, representing a 15% premium to the closing price prior to the agreement. The company also issued multiple warrant series with exercise prices ranging from $0.81 to $1.10 per share, all exercisable for ten years from issuance.
Broader Portfolio Impact
Beyond FemBloc, Femasys maintains a comprehensive women's health portfolio including FemaSeed Intratubal Insemination for fertility treatment and FemVue for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI with a comparable safety profile and high patient and practitioner satisfaction. The FemChec diagnostic product provides ultrasound-based testing to confirm FemBloc procedural success.
With no comparable alternatives currently on the market for non-surgical permanent birth control, FemBloc represents a disruptive advancement with broad global potential in what the company describes as a multi-billion-dollar market opportunity.
